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First At-Home Genetic Test For Breast Cancer Risk Approved

FDA Approves First Direct-to-Consumer Genetic Risk Tests
FDA Approves First Direct-to-Consumer Genetic Risk Tests

The FDA has approved the first at-home genetic test for breast cancer risk. For the first time, the agency authorized 23andMe’s test for 3 BRCA1/BRCA2 breast cancer mutations, which are most common among Ashkenazi Jews.

After DNA analysis from a self-collected saliva sample, the results then detail whether a woman is at an increased risk of developing breast and ovarian cancer and whether a man is at an increased risk of developing breast or prostate cancer. It is important to note that the test only detects 3 out of the more than 1,000 known breast cancer mutations. Furthermore, only a small percentage of Americans carry one of these 3 mutations. Most breast cancer mutations that increase a person’s risk are not detected by this test.

Therefore, you are not completely out of harm’s way if you test negative for the 3 mutations. Due to the mentioned caveats, the agency indicated that patients should not solely rely on this test, nor should the test be used to determine a cancer treatment. Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn’t account for every possible outcome.

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